NCT04485715

Brief Summary

The aim of this study was to assess the performance of AI system in polypectomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 14, 2020

Last Update Submit

July 23, 2020

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

  • polypectomy time

    the time for detection in polypectomy

    12 months

Study Arms (2)

AI-aided group

EXPERIMENTAL
Other: AI system

control group

NO INTERVENTION

Interventions

AI systemOTHER

The real-time assistance of AI system

AI-aided group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to undergo colorectal polypectomy;
  • agree to give written informed consent

You may not qualify if:

  • patients with the contraindications to colorectal polypectomy;
  • patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
  • patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
  • patients refused to participate in the trial;
  • the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
  • the procedure have to be terminated due to complications of anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Interventions

Intelligent Systems

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artificial IntelligenceAlgorithmsMathematical Concepts

Central Study Contacts

Yanqing Li, PhD, MD

CONTACT

86-531-82166095liyanqing@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
gastroenterology professor of Qilu Hospital

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 24, 2020

Study Start

July 21, 2020

Primary Completion

July 21, 2021

Study Completion

September 21, 2021

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

CN(1)